FDA Adverse Event
Malfunction
Summary report: N
GEMSTR 7 THPY ALT ST
MDR report key: 3162371
·
Received June 6, 2013
Report
- Report Number
- 9615050-2013-01552
- Event Type
- Malfunction
- Date Received
- June 6, 2013
- Date of Event
- April 27, 2013
- Report Date
- May 10, 2013
- Manufacturer
- HOSPIRA HOLDINGS DE COSTA RICA LTD.
- Product Code
- FRN
- PMA / PMN Number
- K060806
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
- Health Professional
- Yes
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 503323 | GEMSTR 7 THPY ALT ST | 80FRN | FRN | HOSPIRA HOLDINGS DE COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |